Long-term Study With Clevudine

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A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.

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Ages Eligible for Study:

18 Years to 60 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Patient with DNA levels >=1 x 10^5 copies/mL within 30 days of baseline.

Patient is documented to be HBsAg positive for > 6 months.

Patient has ALT levels >=80 IU/L

Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.

Exclusion Criteria.

Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.

Patients previously treated with interferon within the previous 6 months.

Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]